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510(k) K933086

AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 by Helena Laboratories — Product Code JCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1994
Date Received
June 23, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Hemoglobin, Abnormal
Device Class
Class II
Regulation Number
864.7415
Review Panel
HE
Submission Type

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  • K942222 — QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS (January 20, 1995)
  • K931234 — HEMOCARD CONTROL HB-AA, AE, FAA, FAE (May 11, 1993)
  • K924173 — HEMOCARD(TM) CONTROL (December 1, 1992)
  • K913427 — SICKLE HEMOGLOBIN (HBA/S) CONTROL SET (November 19, 1991)
  • K911347 — LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL (June 10, 1991)
  • K910431 — HEMOCARD CONTROL (March 11, 1991)
  • K820787 — HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL (April 8, 1982)